Medical device recalls High risk

Vyaire Medical, Inc. recalls Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used…

Recall date
April 8, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1730-2024
FDA classification
Class I
Brand / firm
Vyaire Medical, Inc.
Sold / distributed
US nationwide distribution.

Why it was recalled

Potential of the nozzle separating during patient use.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.

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